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Investigating the effect of Holy Quran Voice on delirium prevention after cardiac surgery

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History
# Registration date Revision Id
2 2019-07-01, 1398/04/10 96202
1 2018-11-27, 1397/09/06 68541
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  • Protocol summary

    Prevent Delirium Occurrences
    Investigate the effect of Holy Quran voice on prevention of delirium after cardiac surgery.
    پیشگیری از وقوع دلیریوم
    بررسی تاثیر آوای قرآن بر پیشگیری از بروز دلیریوم پس از جراحی قلب
    This study has intervention and control groups and is blind on one side. The sample size predicted for this study is 106 people and will be randomized into blocks
    This study has intervention and control groups and is blind on one side. The sample size predicted for this study is 108 people and will be randomized into blocks
    این مطالعه دارای گروهای مداخله و کنترل میباشد و یک سو کور میباشد. حجم نمونه پیش بینی شده برای این مطالعه 106 نفر میباشد و به صورت بلوک بندی تصادفی سازی خواهند شد.
    این مطالعه دارای گروه های مداخله و کنترل میباشد و یک سو کور میباشد. حجم نمونه پیش بینی شده برای این مطالعه 108 نفر میباشد و به صورت بلوک بندی تصادفی سازی خواهند شد.
    This study will be carried out at the Golestan Hospital of Ahvaz in the Department of Cardiac Surgery. Blind study will be done using a research fellow. So that the researcher who has the task of evaluating the outcome is not informed about the allocation of patients.
    TIn this randomized clinical trial, 108 patients with cardiac surgery referred to Golestan Hospital in Ahvaz in 2018 will be selected using the consecutive sampling and randomly assigned into groups of experimental and control. In the intervention group, the voice of Quran plays twice daily for 10 minutes each time. Patients are evaluated twice daily for Delirium. In the control group, routine care will be performed. Blind study will be done using a research fellow. So that the researcher who has the task of evaluating the outcome is not informed about the allocation of patients.
    این مطالعه در بیمارستان گلستان اهواز در بخش مراقبت های ویژه جراحی قلب انجام خواهد شد. کورسازی مطالعه با استفاده از همکار پژوهشگر انجام خواهد شد. به نحوی که خود پژوهشگر که وظیفه ارزیابی پیامد را دارد از نحوه تخصیص بیماران اطلاعی نخواهد داشت.
    در این کارآزمایی بالینی تصادفی، 108 بیمار با جراحی قلب بیمارستان گلستان اهواز در سال 2018 با استفاده از نمونه گیری متوالی انتخاب و به صورت تصادفی به گروه های آزمایش و کنترل انتخاب میشوند. در گروه مداخله روزانه دوبار و هر بار به مدت 10 دقیقه آوای قرآن پخش میشود. بیماران روزانه دو بار از نظر بروز دلیریوم ارزیابی میشوند. در گروه کنترل مراقبت روتین انجام میشود.کورسازی مطالعه با استفاده از همکار پژوهشگر انجام خواهد شد. به نحوی که خود پژوهشگر که وظیفه ارزیابی پیامد را دارد از نحوه تخصیص بیماران اطلاعی نخواهد داشت.
    Inclusion Criteria: Age of 18 to above; having the orientation to time, place, person; Being Muslim; Lack of mental disorders; Speak Farsi Exclusion criteria: Alcoholism or substance abuse; having a hearing problem; not having the consent to enter the study
    Inclusion Criteria: Age of 18 to above; having the orientation to time, place, person; Being Muslim; Lack of mental disorders; Talking in Farsi Exclusion criteria: Alcoholism or substance abuse; having a hearing problem; not having the consent to enter the study
    In this study, for the intervention group after extubation, twice a day, each time for 10 minutes, the Quran of Karim with the voice of Abdul Basit Abdul-Samad, which is read in the form of a reciting from the Sura Yusuf, is broadcast using headphones.
    In the intervention group, the voice of the Quran plays twice daily for 10 minutes each time. Patients are evaluated twice daily for Delirium. In the control group, routine care is performed.
    در این مطالعه برای گروه مداخه پس از اکستوباسیون روزانه دوبار و هر بار به مدت 10 دقیقه اوای قران کریم با صدای عبدالباسط عبدالصمد که به صورت ترتیل از سوره یوسف قرائت میگردد با استفاده از هدفون پخش میگردد.
    در گروه مداخله روزانه دوبار و هر بار به مدت 10 دقیقه آوای قرآن پخش میشود. بیماران روزانه دو بار از نظر بروز دلیریوم ارزیابی میشوند. در گروه کنترل مراقبت روتین انجام میشود.

  • General information

    106
    108
    Effect of Qur'anic Voice on Delirium Prevention
    The effect of Holy Quran Voice on Prevention of Delirium
    اثر آوای قران در پیشگیری از دلیریوم
    تاثیر آوای قران در پیشگیری از دلیریوم
    Investigating the effect of the voice of Quran on delirium prevention after cardiac surgery
    Investigating the effect of Holy Quran Voice on delirium prevention after cardiac surgery
    Age of 18 to above
    having orientation to time, place, person
    Being Muslim
    Lack of mental disorders
    Speak Farsi
    Age of 18 to above
    Having orientation to time, place, person
    Being Muslim
    Lack of mental disorders
    Talking in Farsi
    Participants are allocated to treatment or control groups by block randomization. To blind the study, another person who is being studied as a research fellow is used. The colleague of the researcher has the task of assigning patients to the intervention and control groups and the researcher will not know how to allocate patients
    In this study, patients will be randomly assigned to the study. By assigning the letter A to the intervention group and the letter B to the control group, the ABBA ،BABA ،ABAB ،BBAA ،AABB ،BAAB are written in separate sheets and inserted into the container. Then, we randomly take one of these sheets out of the container and write the written compound on it and replace that sheet inside the container. Since the sample size in this study is 108 patients, this procedure is repeated twenty-seven times, and each time the composition is written on each sheet in the sequence of the compound written in the previous sheet is noted. Then each of the letters of a number from one to 108 is assigned sequences written in sequence, and each of the letters is placed inside a packet and written on the envelope of that letter. Each time the patient is selected, one of these packets is opened in the order of the number written on the envelope, and it is determined that the patient should be placed in the intervention or control group.
    بیماران به روش تصادفی سازی بلوکی وارد مطالعه میگردند. جهت کورسازی مطالعه از فرد دیگری که به عنوان همکار پژوهشگر وارد مطالعه میشود استفاده میشود. همکار پژوهشگر وظیفه تخصیص بیماران به دو گروه مداخله و کنترل را دارد و پژوهشگر از نحوه تخصیص بیماران اطلاع نخواهد داشت.
    در این مطالعه، بیماران به صورت تصادفی سازی بلوکی وارد مطالعه خواهند شد. با اختصاص حرف A به گروه مداخله و حرف B به گـروه کنترل، ABBA ،BABA ،ABAB ،BBAA ،AABB ،BAAB در برگه هاي جداگانه نوشـته میشود و در داخل ظرفي انداخته میشود. سپس بـه صـورت تصـادفي يكي از اين برگه هـا را از ظـرف بيـرون می آوریم و تركيب نوشته شـده را مینویسیم و مجدداً آن برگه را در داخل ظرف قرار میدهیم. چـون حجم نمونه در ايـن مطالعـه 108 بيمـار است، ايـن عمل بيست و هفت بار تكرار میشود و هر بار تركيب نوشته شده بر روي هر برگـه در دنبالـه تركيـب نوشـته شده برگه قبلي يادداشت میشود. سپس به هر يك از حروف يك عدد از يك تا 108 به ترتيب حروف يادداشت شده پشت سر هم اختصاص داده میشود و هر يك از حروف داخل يك پاكت گذاشـته میشود و روي پاكت عدد آن حرف نوشته میشود. هر بـار كـه بيمار انتخاب میگردد يكـي از ايـن پاكـتهـا بـه ترتيب عدد نوشته شـده روي پاكـت بـاز شـده و مشخص میشود كه بيمار بايد در گروه آزمون يا کنترل قرار گيرد.

  • Primary outcomes

    #1
    Delirium is one of the oldest known medical disorders, an acute and transient disorder in brain function that is associated with reduced attention and recognition. Delirium is characterized by acute cognitive impairment, fluctuation in mental state, disordered consciousness, neglect, or unorganized thinking.
    Delirium
    دلیریوم یکی از قدیمی ترین اختلالات شناخته شده پزشکی، اختلالی حاد و گذرا در عملکرد مغز است که با کاهش توجه و شناخت همراه می باشد. دلیریوم با نقصان شناختی حاد، نوسان در وضعیت ذهنی، اختلال آگاهی، بی توجهی یا تفکر سازمان نیافته شناخته می شود.
    دلیریوم
    The Confusion Assessment Method for the ICU (CAM-ICU) The CAM-ICU tool examines the four main characteristics of delirium (acute change or fluctuation of patient mental state, distraction, disturbances of consciousness, and unorganized thinking). Delirium is positive if criterion 1 is followed by criterion 2 and one of criteria 3 or 4. This tool has yes or no response, and it takes 2-5 minutes to complete and can be completed by a doctor or nurse.
    The Confusion Assessment Method for the ICU (CAM-ICU)
    پرسشنامه (The Confusion Assessment Method for the ICU (CAM-ICU ابزار CAM-ICU چهار ويژگي اصلي دليريوم( تغيير حاد يا سير نوساني وضعيت ذهني بيمار، عدم تمرکز، اختلال سطح هوشياري و تفکر سازماندهي نشده) را مورد بررسي قرار مي دهد. دليريوم در صورتي مثبت مي شود كه معیار 1 همراه با معيار 2 و يكي از معيارهای 3 يا 4 باشد. اين ابزار داراي پاسخ هاي بله و خير مي باشد و پر كردن آن 2-5 دقيقه زمان نياز دارد و مي تواند توسط پزشك يا پرستار تكميل گردد.
    پرسشنامه (The Confusion Assessment Method for the ICU (CAM-ICU

  • Secondary outcomes

    #1
    empty
    Sleep score
    empty
    نمره خواب
    empty
    The researcher will assess the quality and quantity once a day at 12 noon.
    empty
    پژوهشگر روزانه یک بار در ساعت 12 ظهر اقدام به ارزیابی کیفیت و کمیت خواهد پرداخت.
    empty
    Richard Campbell questionnaire.
    empty
    پرسشنامه ریچارد کمپل
    #2
    empty
    Anxiety Score
    empty
    نمره اضطراب
    empty
    The level of anxiety will be evaluated on the first day of admission and on the day of discharge.
    empty
    سطح اضطراب در روز اول بستری و در روز ترخیص مورد ارزیابی قرار خواهد گرفت.
    empty
    Hospital Anxiety and Depression Scale (HADS)
    empty
    مقياس بيمارستاني اضطراب و افسردگي

  • Intervention groups

    #1
    Intervention group: For the intervention group, after extubation, twice a day, and each time, for ten minutes, the Quran of the Holy Qur'an is broadcast by headphones with the voice of Master Abdul Baset, which is read in the form of a trilate from the Surah Yusuf.
    "Intervention group": After the extubation of the patient, the voice of the Quran will be broadcast twice a day by the headphones for ten minutes.
    گروه مداخله: برای گروه مداخله پس ز اکستوباسیون روزانه دوبار و هر بار به مدت ده دقیقه اوای قرآن کریم با صدای استاد عبدالباسط که به صورت ترتیل از سوره یوسف قرائت میگردد به وسیله هدفون پخش میشود.
    "گروه مداخله": پس از اکستوباسیون بیمار، دوبار در روز آوای قرآن به مدت ده دقیقه توسط هدفون پخش خواهد شد.
    #2
    empty
    Prevention
    empty
    Control group: routine care is provided in this group.
    empty
    گروه کنترل: مراقبت روتین در این گروه صورت میگیرد.

  • Person responsible for general inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Seyed Farhan Mousavi
    Full name of responsible person - Persian: سید فرحان موسوی
    Position - English: Student
    Position - Persian: دانشجو
    Latest degree: bachelor
    Area of specialty/work: 27
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: No3; Ayatollah Taleghani
    Street address - Persian: خیابان ایت الله طالقانی پلاک 3
    City - English: Shushtar
    City - Persian: شوشتر
    Province: Khouzestan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 6459119145
    Phone: +98 36 2789
    Mobile: +98 916 909 4759
    Fax:
    Email: Farhanmuosavi@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Seyed Farhan Mousavi
    Full name of responsible person - Persian: سید فرحان موسوی
    Position - English: Student
    Position - Persian: دانشجو
    Latest degree: bachelor
    Area of specialty/work: 27
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: No. 3, Ayatollah Taleghani Ave.
    Street address - Persian: خیابان ایت الله طالقانی پلاک 3
    City - English: Shushtar
    City - Persian: شوشتر
    Province: Khouzestan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 6459119145
    Phone: +98 362789
    Mobile: +98 916 909 4759
    Fax:
    Email: Farhanmuosavi@gmail.com
    Web page address:

  • Person responsible for scientific inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Mohammad reza Heidari
    Full name of responsible person - Persian: محمدرضا حیدری
    Position - English: assistant professor
    Position - Persian: استادیار
    Latest degree: phd
    Area of specialty/work: 27
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Tehran, Shahed university
    Street address - Persian: تهران، بزرگراه خلیج فارس ( تهران - قم ) ، رو به روی حرم مطهر امام خمینی (ره) ، دانشگاه شاهد
    City - English: tehran
    City - Persian: شوشتر
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 6459119145
    Phone: +98 61212146
    Mobile: +98 912 345 1392
    Fax:
    Email: mheidari@shahed.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Mohammad Reza Heidari
    Full name of responsible person - Persian: محمدرضا حیدری
    Position - English: Assistant Professor
    Position - Persian: استادیار
    Latest degree: phd
    Area of specialty/work: 27
    Area of specialty/work title - English: Nursing
    Area of specialty/work title - Persian: پرستاری
    Street address - English: Department of Nursing, Shahed University, Tehran-Qom Express Way, Opposite Imam Khomeini's Shrine, 3319118651, Tehran, Iran.
    Street address - Persian: تهران، بزرگراه تهران - قم، رو به روی حرم مطهر امام خمینی (ره)، دانشگاه شاهد، گروه پرستاری.
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 3319118651
    Phone: +98 51212146
    Mobile: +98 912 345 1392
    Fax:
    Email: mheidari@shahed.ac.ir
    Web page address:

  • Person responsible for updating data


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Seyed Farhan Mousavi
    Full name of responsible person - Persian: سید فرحان موسوی
    Position - English: Student
    Position - Persian: دانشجو
    Latest degree: bachelor
    Area of specialty/work: 27
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: No 3; Street Ayatollah
    Street address - Persian: خیابان ایت الله طالقانی پلاک 3
    City - English: Shushtar
    City - Persian: شوشتر
    Province: Khouzestan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 6459119145
    Phone: +98 36 16789
    Mobile: +98 916 909 4759
    Fax:
    Email: farhanmuosavi@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Seyed Farhan Mousavi
    Full name of responsible person - Persian: سید فرحان موسوی
    Position - English: Student
    Position - Persian: دانشجو
    Latest degree: bachelor
    Area of specialty/work: 27
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: No. 3, Ayatollah Taleghani Ave.
    Street address - Persian: خیابان ایت الله طالقانی، پلاک 3
    City - English: Shushtar
    City - Persian: شوشتر
    Province: Khouzestan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 6459119145
    Phone: +98 3616789
    Mobile: +98 916 909 4759
    Fax:
    Email: farhanmuosavi@gmail.com
    Web page address:

Protocol summary

Study aim
Investigate the effect of Holy Quran voice on prevention of delirium after cardiac surgery.
Design
This study has intervention and control groups and is blind on one side. The sample size predicted for this study is 108 people and will be randomized into blocks
Settings and conduct
TIn this randomized clinical trial, 108 patients with cardiac surgery referred to Golestan Hospital in Ahvaz in 2018 will be selected using the consecutive sampling and randomly assigned into groups of experimental and control. In the intervention group, the voice of Quran plays twice daily for 10 minutes each time. Patients are evaluated twice daily for Delirium. In the control group, routine care will be performed. Blind study will be done using a research fellow. So that the researcher who has the task of evaluating the outcome is not informed about the allocation of patients.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Age of 18 to above; having the orientation to time, place, person; Being Muslim; Lack of mental disorders; Talking in Farsi Exclusion criteria: Alcoholism or substance abuse; having a hearing problem; not having the consent to enter the study
Intervention groups
In the intervention group, the voice of the Quran plays twice daily for 10 minutes each time. Patients are evaluated twice daily for Delirium. In the control group, routine care is performed.
Main outcome variables
Delirium

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171222037990N1
Registration date: 2018-11-27, 1397/09/06
Registration timing: registered_while_recruiting

Last update: 2019-07-09, 1398/04/18
Update count: 1
Registration date
2018-11-27, 1397/09/06
Registrant information
Name
Farhan Mousavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 2621 6789
Email address
f.mousavi@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-22, 1397/09/01
Expected recruitment end date
2019-02-04, 1397/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of Holy Quran Voice on delirium prevention after cardiac surgery
Public title
The effect of Holy Quran Voice on Prevention of Delirium
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to above Having orientation to time, place, person Being Muslim Lack of mental disorders Talking in Farsi
Exclusion criteria:
Alcoholism or substance abuse Having a hearing problem Not having the consent to enter the study
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 108
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, patients will be randomly assigned to the study. By assigning the letter A to the intervention group and the letter B to the control group, the ABBA ،BABA ،ABAB ،BBAA ،AABB ،BAAB are written in separate sheets and inserted into the container. Then, we randomly take one of these sheets out of the container and write the written compound on it and replace that sheet inside the container. Since the sample size in this study is 108 patients, this procedure is repeated twenty-seven times, and each time the composition is written on each sheet in the sequence of the compound written in the previous sheet is noted. Then each of the letters of a number from one to 108 is assigned sequences written in sequence, and each of the letters is placed inside a packet and written on the envelope of that letter. Each time the patient is selected, one of these packets is opened in the order of the number written on the envelope, and it is determined that the patient should be placed in the intervention or control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The colleague of the researcher will be responsible for assigning patients to the control and intervention groups, and the researcher who has the task of evaluating the outcome will not know how to allocate patients.
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The Ethics Committee for Medical Research at Shahed University
Street address
shahed university
City
tehran
Province
Tehran
Postal code
3319118651
Approval date
2018-10-29, 1397/08/07
Ethics committee reference number
IR.SHAHED.REC.1397.056

Health conditions studied

1

Description of health condition studied
Delirium
ICD-10 code
F05
ICD-10 code description
Delirium due to known physiological condition

Primary outcomes

1

Description
Delirium
Timepoint
In this study, delirium is evaluated twice daily at 10 to 11 and 17 to 18 .
Method of measurement
The Confusion Assessment Method for the ICU (CAM-ICU)

Secondary outcomes

1

Description
Sleep score
Timepoint
The researcher will assess the quality and quantity once a day at 12 noon.
Method of measurement
Richard Campbell questionnaire.

2

Description
Anxiety Score
Timepoint
The level of anxiety will be evaluated on the first day of admission and on the day of discharge.
Method of measurement
Hospital Anxiety and Depression Scale (HADS)

Intervention groups

1

Description
"Intervention group": After the extubation of the patient, the voice of the Quran will be broadcast twice a day by the headphones for ten minutes.
Category
Prevention

2

Description
Control group: routine care is provided in this group.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Golestan hospital
Full name of responsible person
Seyed Farhan Mousavi
Street address
Golestan Ave
City
Ahwaz
Province
Khouzestan
Postal code
6459119145
Phone
+98 61 3374 3001
Email
farhanmuosavi@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahed University
Full name of responsible person
Zahra Kia Salari
Street address
Freedom of the Persian Gulf, Shahed University
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 5080
Email
info@shahed.ac.ir
Web page address
http://shahed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahed University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shahed University
Full name of responsible person
Seyed Farhan Mousavi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 3, Ayatollah Taleghani Ave.
City
Shushtar
Province
Khouzestan
Postal code
6459119145
Phone
+98 362789
Email
Farhanmuosavi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahed University
Full name of responsible person
Mohammad Reza Heidari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursing
Street address
Department of Nursing, Shahed University, Tehran-Qom Express Way, Opposite Imam Khomeini's Shrine, 3319118651, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 51212146
Email
mheidari@shahed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahed University
Full name of responsible person
Seyed Farhan Mousavi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 3, Ayatollah Taleghani Ave.
City
Shushtar
Province
Khouzestan
Postal code
6459119145
Phone
+98 3616789
Email
farhanmuosavi@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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